C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population (C-PATROL)
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| ClinicalTrials.gov Identifier: NCT02503436 |
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Recruitment Status :
Completed
First Posted : July 21, 2015
Last Update Posted : January 10, 2023
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.
| Condition or disease |
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| Ovarian Cancer, Hereditary Ovarian Cancer Syndrome |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 276 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 84 Months |
| Official Title: | C-PATROL - a Single Arm, Prospective Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population |
| Actual Study Start Date : | October 28, 2015 |
| Actual Primary Completion Date : | December 1, 2022 |
| Actual Study Completion Date : | December 1, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
Primary Outcome Measures :
- To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision. [ Time Frame: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months ]
Secondary Outcome Measures :
- To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS) [ Time Frame: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months ]
- Time to first subsequent therapy (TFST) [ Time Frame: Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months ]
- Progression-free survival 2 (PFS2) [ Time Frame: Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months ]
- Time to second subsequent therapy (TSST) [ Time Frame: Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months ]
- Time to discontinuation of olaparib monotherapy (TDO) [ Time Frame: Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months ]
- Assessment of health-related quality of life (HRQoL) in patients participating in the study. [ Time Frame: Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months ]
Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires:
- Functional assessment of Cancer Therapy for Patients with Ovarian Cancer (FACT-O)
- Functional Assessment of Chronic Illness - Fatigue (FACIT-Fatigue)
- Functional Living Index - Emesis (FLIE)
- Safety of Olaparib: collection of Adverse Events (AE) [ Time Frame: Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months ]Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
300 patients in 80 sites (approx. 40 hospitals and 40 outpatient practices) in Germany. Each site should enrol 2-30 patients
Criteria
Inclusion Criteria:
- Signed written informed consent
- Women aged ≥ 18 years
- Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
- Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
- Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
- Patients are able to read and understand German, English, Turkish or Arabic
Exclusion Criteria:
- Known hypersensitivity to olaparib or any of the excipients of the drug
- Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
- Pregnancy or breast feeding
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503436
Locations
Show 68 study locations
Sponsors and Collaborators
AstraZeneca
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT02503436 |
| Other Study ID Numbers: |
D0816R00009 |
| First Posted: | July 21, 2015 Key Record Dates |
| Last Update Posted: | January 10, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by AstraZeneca:
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Ovarian Cancer, Fallopian Tube Cancer, primary peritoneal cancer, BRCA1 Gene, BRCA2 Gene |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |